Actively Recruiting
Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Led by Abdelrahman Mahmoud · Updated on 2026-01-13
66
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
We investigate the role of empagliflozin in the treatment of obesity in PLWH.
CONDITIONS
Official Title
Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years and up to 65 years old
- Body Mass Index (BMI) greater than 30 kg/m²
- Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen with dolutegravir
- Sustained virologic suppression with HIV-1 RNA less than 200 copies/mL for at least 6 months
- Current CD4 count greater than 250 cells/mL
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Diagnosis of Diabetes Mellitus with fasting blood glucose greater than 126 mg/dL or HbA1c greater than 6.5%
- Renal impairment with eGFR less than 60 ml/min/1.73m²
- Active viral hepatitis B or C infection
- Hypersensitivity to empagliflozin or its components
- Pregnancy or breastfeeding
- Current use of other SGLT-2 inhibitors
- Use of drugs that interact with empagliflozin or dolutegravir (e.g., rifampin, phenytoin, antacids, carbamazepine)
- Current or recent use of medications known to cause significant weight gain (e.g., systemic corticosteroids, antipsychotics, mood stabilizers)
- Known thyroid disease with TSH greater than 6.0 mIU/L or less than 0.35 mIU/L
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Pharmacy, Cairo University | Kasr El-Aini, Cairo
Cairo, Egypt, 11562
Actively Recruiting
Research Team
A
Abdelrahman Dosoky, Bachelor's degree
CONTACT
A
Ahmed Kamel, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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